approvalsWatch: Oncology 201115
US FDA Approvals
Osimertinib & cobas EGFR Mutation Test v2
The third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor osimertinib has been approved by the US FDA for the treatment of advanced non-small-cell lung cancer patients with tumours harbouring the T790M EGFR mutation who have progressed on other anti-EGFR agents.
The US FDA has also approved the cobas EGFR Mutation Test v2, a companion diagnostic test to detect the T790M mutation in DNA derived from formalin-fixed, paraffin-embedded tumour tissue.
Accelerated approval has been granted for the anti-CD38 monoclonal antibody daratumumab for patients with multiple myeloma who have received a minimum of three previous treatments. Daratumumab is the first monoclonal antibody approved for this condition.
The proteasome inhibitor Ixazomib, given in combination with lenalidomide and dexamethasone, has been approved for the treatment of multiple myeloma patients who have received at least one previous therapy.
European Medicines Agency Approvals
Pegaspargase has been given a marketing authorisation by the EMA’s Committee for Medicinal Products for Human Use for administration as a component of antineoplastic combination therapy for paediatric and adult patients with acute lymphoblastic leukaemia. Pegaspargase is the pegylated form of L-asparaginase and has been previously been approved in Germany and Poland for patients sensitive to native forms of the enzyme.
Asparaginase has been granted a marketing authorisation for the treatment of acute lymphoblastic leukaemia in paediatric patients from birth to 18 years and adult patients as part of antineoplastic combination therapy. The antineoplastic agent was previously designated as an orphan medicinal product.